In this study different doses of Heparin in prophylaxis of Deep Vein Thrombosis following laparoscopic bariatric surgery will be compared. Pre-operative information will be gathered and baseline assessment will be done in obesity patients who have laparoscopic bariatric surgery and accept the invitation to participate in this study. Those patients who do not show any sign of thrombosis in their first doppler ultrasound, will be allocated into the study groups (group 1 and group 2). Each of the groups 1 and 2 consists of 350 patients which will receive 10000 units and 15000 units Heparin for 14 days, respectively. Color Doppler sonography assessment will be done in order to diagnose femoral, popliteal, and calf vein deep veins thrombosis (DVT). Color Doppler assessment will be performed pre operatively and on the second and tenth post operative days and the results will be recorded in relevant Case Report Forms (patients booklets). After discharge, patients will be followed by the corresponding researcher and information on occurrence of DVT will be documented. The results will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008253384N3
Registration date:2010-10-05, 1389/07/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-10-05, 1389/07/13
Registrant information
Name
Ameneh Ebrahim Valoojerdi
Name of organization / entity
Endocrine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
info@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different doses of Heparin in prophylaxis of Deep vein Thrombosis following laparoscopic bariatric surgery ; A Randomized Clinical Trial
Public title
Effect of different doses of Heparin in prophylaxis of Deep vein Thrombosis following laparoscopic bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Obesity patients who have laparoscopic bariatric surgery
Exclusion criteria: Patients who have positive result of clots in first Doppler ultrasound
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
700
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences , Hemat highway
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
1/891
Health conditions studied
1
Description of health condition studied
Deep vein thrombosis
ICD-10 code
I80.0, I80
ICD-10 code description
Phlebitis and thrombophlebitis
Primary outcomes
1
Description
Deep vein thrombosis
Timepoint
Before surgery, two days after surgery, 10 days after surgery
Method of measurement
Doppler sonography
Secondary outcomes
empty
Intervention groups
1
Description
15,000 units heparin 14 days
Category
Treatment - Drugs
2
Description
10000 units heparin 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
4
Recruitment center
Name of recruitment center
Parsian Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Maziar Moradi
Street address
Iran University of Medical Sciences - HEMAT highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?